Immuno-Mycolog: Candida ID Antigen products may give false negative results. Recalled due to reduced sensitivity. Contact for replacement.
Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results.
Immuno-Mycologics is recalling Candida ID Antigen test kits because they might give false negative results. This means the test could miss infections that are actually present, which is risky for people needing accurate diagnosis.
The test kits may have reduced sensitivity, meaning they might not detect Candida infections properly. This could lead to false negative results where the test shows no infection when one actually exists. For people needing accurate diagnosis, this could delay proper treatment.
People using these Candida ID Antigen test kits for medical diagnosis, especially those with suspected fungal infections. Those who rely on these tests for accurate results are most at risk.
Check for the product names: Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL, REF ID1001, Immy Fungal Antigens, Positive Controls, and Immunodiffusion plates. These are for medical use only and sold with specific lot numbers.
Look for the product names and lot numbers listed in the recall notice to confirm if your kit is affected.
The Candida ID Antigen test kits may have reduced sensitivity, which could result in false negative results.
The recall notice does not specify a remedy or action for affected products.
The recall indicates a potential risk of false negative results, but the product is not unsafe in normal use.
We’ve drafted a message you can send Immuno-Mycologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1389-2025 — Immuno-Mycologics Immuno-Mycologics Hello, I own a Immuno-Mycologics that is covered by recall Z-1389-2025 from Immuno-Mycologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
